BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNVISC ONE GLASS SYRINGE:

    MDR report key: 18571469 · Received January 24, 2024

    Report

    Report Number
    18571469
    Event Type
    Malfunction
    Date Received
    January 24, 2024
    Date of Event
    September 6, 2023
    Report Date
    September 12, 2023
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PROCEDURE STARTED OUT NORMALLY WITH NORMAL PREPARATION OF THE RIGHT KNEE FOR INJECTION, INCLUDING CLEANING WITH CHLORAPREP AND NUMBING SPRAY AND STERILE GLOVES ON PROVIDER. LIDOCAINE WAS INJECTED INTO THE RIGHT KNEE PER NORMAL PROCEDURE, AND THEN THE NEEDLE WAS LEFT INTACT IN THE PATIENT¿S RIGHT KNEE. THE SYRINGE WAS SWITCHED TO THE SYNVISC ONE SYRINGE USING STERILE TECHNIQUE. UPON INITIAL DEPRESSION OF THE SYRINGE TO ATTEMPT TO PUSH THE CONTENTS OF THE SYNVISC-ONE SYRINGE INTO THE KNEE, THE GLASS STOPPER FOR THE PLUNGER SHATTERED WITH APPLICATION OF MILD FORCE. THERE WERE NO CONTENTS OF SYNVISC-ONE INJECTED INTO THE PATIENT¿S KNEE, AND THE NEEDLE WAS IMMEDIATELY REMOVED FROM THE KNEE. THE PATIENT REPORTED NO ILL EFFECTS OR INJURY. SUSPECT A FAULTY GLASS SYRINGE. THE PROVIDER DID HAVE THEIR RIGHT INDEX FINGER AND MIDDLE FINGER LACERATED WITH THE BROKEN GLASS. AFTER CLEANING UP THE GLASS AND BROKEN SYRINGE, A NEW SYNVISC ONE SYRINGE WAS OBTAINED AS WELL AS A NEW 18 GAUGE NEEDLE AND INJECTION OF SYNVISC-ONE WAS REPEATED SUCCESSFULLY. NO FURTHER LIDOCAINE WAS INJECTED WITH THE SECOND INJECTION. THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2061075 SYNVISC ONE GLASS SYRINGE: ACID, HYALURONIC, INTRAARTICULAR MOZ GENZYME CORPORATION DRSL021A

    Patients

    Seq Age Sex Outcome Treatment
    1 19345 DA Female